MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEGURA HEMISPHERE; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063801100
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemi basket was used in the kidney during a ureteroscopy laser lithotripsy procedure performed on an unknown date.During the procedure, the basket was deployed in the kidney and captured a stone.However, the stone was too large to remove through the ureter.The basket was attempted to open to release the stone but it failed to open.A holmium laser was used to dismantle the basket and successfully released the stone.The basket was then removed and the stone was fragmented.Another segura hemi basket was used to removed the stone fragments and complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemi basket was used in the kidney during a ureteroscopy laser lithotripsy procedure performed on an unknown date.During the procedure, the basket was deployed in the kidney and captured a stone.However, the stone was too large to remove through the ureter.The basket was attempted to open to release the stone but it failed to open.A holmium laser was used to dismantle the basket and successfully released the stone.The basket was then removed and the stone was fragmented.Another segura hemi basket was used to removed the stone fragments and complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: device code a0401 captures the reportable event of basket failure to release stone.Block h10: the returned segura hemisphere basket was analyzed, and a visual evaluation noted that the basket was received retracted.The basket was found detached when the handle was actuated.Functional inspection confirmed the device will extend/retracted without any issues.Microscope inspection observed the basket has traces of burns.The reported event of "basket failure to released stone" was not confirmed.Based on all available information, there is evidence that the failure to release maybe associated with the irretrievable size of the stone.However, this cannot be confirmed because of the condition of the returned device.There is evidence that the device was used in a manner inconsistent with the written instruction of the instructions for use (ifu).The basket detached condition was generated because the physician did not verify the ifu and cited that the stone was too large to remove through the ureter and as a consequence, the physician used holmium laser to dismantle the basket.This is not contemplated in the ifu.Therefore, the conclusion code is failure to follow instructions because the problem traced to the user not following the manufacturer's instructions.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and there was evidence that the device was used in a manner inconsistent with a written instruction in the instructions for use (ifu).

• Brand Name: SEGURA HEMISPHERE
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14636586
• Report Number: 3005099803-2022-03232
• Device Sequence Number: 17675078
• Product Code: FFL
• UDI-Device Identifier: 08714729341925
• UDI-Public: 08714729341925
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2024
• Device Model Number: M0063801100
• Device Catalogue Number: 380-110
• Device Lot Number: 0027932155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown